Cleared Traditional

K153070 - Watch-PAT200U

K153070 is an FDA 510(k) clearance for Watch-PAT200U, manufactured by Itamar Medical , Ltd.. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K153070 · Itamar Medical , Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
278d
Days
Class 2
Risk

K153070 is an FDA 510(k) clearance for the Watch-PAT200U. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Itamar Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on July 26, 2016 after a review of 278 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - the FDA anesthesiology and respiratory device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Itamar Medical , Ltd. devices

FDA 510(k) Submission Details - K153070

510(k) Number K153070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2015
Decision Date July 26, 2016
Days to Decision 278 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
138d slower than avg
Panel avg: 140d · This submission: 278d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNR Device Classification - Class 2, Special Controls

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Consultant

Hogan Lovells US LLP
JONATHAN KAHAN

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 151
Devices cleared under the same product code (MNR) and FDA review panel - the closest regulatory comparables to K153070.
MATRx plus
K163665 · Zephyr Sleep Technologies · May 2017
Apnea Risk Evaluation System (ARES), Model 620
K160499 · Watermark Medical · Apr 2017
Watch-PAT200U
K161579 · Itamar Medical , Ltd. · Feb 2017
BiNAPS Nasal Airflow and Snore Transducer
K151874 · Salter Labs · Apr 2016
AUDICOR CA300/CC100 Analyzer with SDB
K151433 · Inovise Medical, Inc. · Mar 2016
Nox RIP Belts & Cables
K151361 · Nox Medical Ehf · Nov 2015